Important Information About KEYTRUDA®
(pembrolizumab) injection 100 mg.
Please speak with your healthcare professional regarding KEYTRUDA (pronounced key-true-duh). Only your healthcare professional knows the specifics of your condition and how KEYTRUDA may work with your overall treatment plan. If you have any questions about KEYTRUDA, speak with your healthcare professional. ONLY
What is the most important information I should know about KEYTRUDA?
KEYTRUDA is a medicine that may treat certain cancers by working with your immune system. KEYTRUDA can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. These problems may happen anytime during treatment or even after your treatment has ended.
Call or see your doctor right away if you develop any symptoms of the following problems or these symptoms get worse: Lung problems (pneumonitis).
Symptoms of pneumonitis may include:
• shortness of breath
• chest pain
• new or worse cough
Intestinal problems (colitis) that can lead to tears or holes in your intestine.
Signs and symptoms of colitis may include:
• diarrhea or more bowel movements than usual
• stools that are black, tarry, sticky, or have blood or mucus
• severe stomach-area (abdomen) pain or tenderness
Liver problems, including hepatitis.
Signs and symptoms of liver problems may include:
• yellowing of your skin or the whites of your eyes
• nausea or vomiting
• pain on the right side of your stomach area (abdomen)
• dark urine
• bleeding or bruising more easily than normal
Hormone gland problems (especially the thyroid, pituitary, adrenal glands, and pancreas).
Signs and symptoms that your hormone glands are not working properly may include:
• rapid heart beat
• weight loss or weight gain
• increased sweating
• feeling more hungry or thirsty
• urinating more often than usual
• hair loss
• feeling cold
• constipation
• your voice gets deeper
• muscle aches
• feeling very weak
• dizziness or fainting
• headaches that will not go away or unusual headache
Kidney problems, including nephritis and kidney failure.
Signs of kidney problems may include:
• change in the amount or color of your urine
Skin problems.
Signs of skin problems may include: • rash
• itching
• blisters, peeling or skin sores
• painful sores or ulcers in your mouth or in your nose, throat, or genital area
Problems in other organs.
Signs and symptoms of these problems may include:
• changes in eyesight
• severe or persistent muscle or joint pains
• severe muscle weakness
• low red blood cells (anemia)
• swollen lymph nodes, rash or tender lumps on skin, cough, shortness of breath, vision changes, or eye pain (sarcoidosis)
• confusion, fever, muscle weakness, balance problems, nausea, vomiting, stiff neck, memory problems, or seizures (encephalitis)
• pain, numbness, tingling, or weakness in your arms or legs, or bladder or bowel problems, including the need to urinate more often, leaking of urine, trouble urinating, or constipation (myelitis)
• shortness of breath, irregular heartbeat, feeling tired, or chest pain (myocarditis)
Infusion (IV) reactions that can sometimes be severe and lifethreatening.
Signs and symptoms of infusion reactions may include: • chills or shaking
• shortness of breath or wheezing
• itching or rash
• flushing • dizziness
• fever
• feeling like passing out
Rejection of a transplanted organ.
People who have had an organ transplant may have an increased risk of organ transplant rejection. Your doctor should tell you what signs and symptoms you should report and monitor you, depending on the type of organ transplant that you have had.
Complications, including graft-versus-host-disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic).
These complications can be severe and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with KEYTRUDA. Your doctor will monitor you for the following
signs and symptoms: skin rash, liver inflammation, stomach-area (abdominal) pain, and diarrhea.
Getting medical treatment right away may help keep these problems from becoming more serious.
Your doctor will check you for these problems during treatment with KEYTRUDA. Your doctor may treat you with corticosteroid or hormone replacement medicines. Your doctor may also need to delay or completely stop treatment with KEYTRUDA, if you have severe side effects.
What should I tell my doctor before receiving KEYTRUDA? Before you receive KEYTRUDA, tell your doctor if you:
• have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
• have received an organ transplant, such as a kidney or liver
• have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
• have lung or breathing problems
• have liver problems
• have any other medical problems
• are pregnant or plan to become pregnant
KEYTRUDA can harm your unborn baby.
Females who are able to become pregnant:
Your doctor will give you a pregnancy test before you start treatment with KEYTRUDA.
You should use an effective method of birth control during and for at least 4 months after the final dose of KEYTRUDA. Talk to your doctor about birth control methods that you can use during this time.
Tell your doctor right away if you think you may be pregnant or if you become pregnant during treatment with KEYTRUDA.
• are breastfeeding or plan to breastfeed.
It is not known if KEYTRUDA passes into your breast milk.
Do not breastfeed during treatment with KEYTRUDA and for 4 months after your final dose of KEYTRUDA.
Tell your doctor about all the medicines you take,
including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
How will I receive KEYTRUDA?
• Your doctor will give you KEYTRUDA into your vein through an intravenous (IV) line over 30 minutes.
• In adults, KEYTRUDA is usually given every 3 weeks or 6 weeks depending on the dose of KEYTRUDA that you are receiving.
• In children, KEYTRUDA is usually given every 3 weeks.
• Your doctor will decide how many treatments you need.
• Your doctor will do blood tests to check you for side effects.
• If you miss any appointments, call your doctor as soon as possible to reschedule your appointment.
What are the possible side effects of KEYTRUDA? KEYTRUDA can cause serious side effects. See “What is the most important information I should know about KEYTRUDA?”
Common side effects of KEYTRUDA when used alone include:
feeling tired, pain, including pain in muscles, bones or joints and stomach-area (abdominal) pain, decreased appetite, itching, diarrhea, nausea, rash, fever, cough, shortness of breath, and constipation.
Common side effects of KEYTRUDA when given with certain chemotherapy medicines include:
feeling tired or weak, nausea, constipation, diarrhea, decreased appetite, rash, vomiting, cough, trouble breathing, fever, hair loss, inflammation of the nerves that may cause pain, weakness, and paralysis in the arms and legs, swelling of the lining of the mouth, nose, eyes, throat, intestines, or vagina, and mouth sores.
Common side effects of KEYTRUDA when given with axitinib include:
diarrhea, feeling tired or weak, high blood pressure, liver problems, low levels of thyroid hormone, decreased appetite, blisters or rash on the palms of your hands and soles of your feet, nausea, mouth sores or swelling of the lining of the mouth, nose, eyes, throat, intestines, or vagina, hoarseness, rash, cough, and constipation.
In children, feeling tired, vomiting and stomach-area (abdominal) pain, and increased levels of liver enzymes and decreased levels of salt (sodium) in the blood are more common than in adults.
These are not all the possible side effects of KEYTRUDA. For more information, ask your doctor or pharmacist.
Tell your doctor if you have any side effect that bothers you or that does not go away.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of KEYTRUDA
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. If you would like more information about KEYTRUDA, talk with your doctor. You can ask your doctor or nurse for information about KEYTRUDA that is written for healthcare professionals. For more information, go to www.keytruda.com.
Based on Medication Guide usmg-mk3475-iv-2006r032 as revised June 2020.